First time ordering compounded - what do I even look for??

nick_newbie ↑ said:

My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 5 different compounding pharmacies over the past 18 months. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.

My current compounder (a 503B facility) has been consistently 98-101% purity across 5 orders. I pay $112/month vs $1,302 for brand. The savings are substantial and the product is equivalent in my experience.

Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.

Dr.PeteFamMed ↑ said:

A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

GMP compliance checklist relevant to compounded supply compounding quality:

• Clean room environment with HEPA filtration
• Environmental monitoring (viable and non-viable)
• Personnel training and competency assessment
• Validated analytical methods for testing
• Stability testing program
• Complete batch records and traceability
• Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

A narrower follow-up, since the general answer is now clear:

What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?

Closing the loop on my own question.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.